Horizon Pharma plc
Horizon Pharma plc Announces That Health Canada Determines RAVICTI(R) (Glycerol Phenylbutyrate) Oral Liquid Is Eligible for Data Protection
DUBLIN, IRELAND -- (Marketwired) -- 02/22/16 -- Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that the Therapeutic Products Directorate of Health Canada has determined that RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid is eligible for data protection as it is an "innovative drug" as defined by section C.08.004.1 Food and Drug Regulations.
Subject to final review, if the RAVICTI New Drug Submission (NDS) receives a notice of compliance, RAVICTI would be added to the Register of Innovative Drugs and receive data protection for a term of eight years from the date of the issuance of the notice of compliance. The RAVICTI NDS was originally filed on April 24, 2014 and has been the subject of a stay since June 12, 2015 pending a final determination on data protection.
"This decision is a significant step toward making RAVICTI available in Canada and we look forward to reinitiating the regulatory review process in order to get this innovative medicine to the approximately 100 patients who have urea cycle disorders and who may benefit from treatment as quickly as possible," said Jared Rhines, vice president and general manager, Canada, LATAM and APAC, Horizon Pharma plc.